The ongoing Phase 2b clinical trial evaluates efficacy on motor nerve conduction velocity, clinical outcomes, and visual acuity.
"While there are many drugs available to patients and physicians for the treatment of the symptoms of this disease, there are no therapies available to change the rate of progression of the underlying disease. This drug holds the promise to have a meaningful effect on the outcome of the major complications of Type 2 diabetes," – said Vera Bril, MD, Professor of Medicine (Neurology) at the University of Toronto, Director of Neurology at Mount Sinai Hospital, and the Principal Investigator of the Phase 2b study.
"Assuming a positive trial outcome, Bionevia is targeting an End of Phase 2 Meeting with the FDA for the second half of 2017 where we hope to establish a clinical path forward for approval in the US," – said Timothy Barberich, Chairman of Bionevia.
"Together with previously conducted supporting preclinical and clinical studies of BNV-222, which showed a favorable safety profile, the companies believe that the current Phase 2b trial results will enable the filing and approval for marketing in Russia," – said Julia Moskot, NeuroMax Program Director.
About BNV-222
BVN-222 is a potential disease modifying, first-in-class treatment for slowing or arresting diabetic neuropathy, a progressive disease. BNV-222 is a novel extended release formulation of diepalrestat, a cocrystal of epalrestat, a reversible aldose reductase inhibitor which blocks the breakdown of excess blood glucose into sorbitol, preventing long-term nerve and tissue damage.